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PMS of Trazenta on the Long-term Use as Add-on Therapy

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ClinicalTrials.gov Identifier: NCT01904383
Recruitment Status : Active, not recruiting
First Posted : July 22, 2013
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Trazenta

Study Type : Observational
Actual Enrollment : 4058 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : July 1, 2013
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Trazenta Drug: Trazenta
1 tablet of 5 mg Trazenta tablets once daily



Primary Outcome Measures :
  1. The primary endpoint to assess safety of Trazenta Tablets is the number (%) of patients with drug related adverse events [ Time Frame: up to 156 weeks ]

Secondary Outcome Measures :
  1. Incidence of serious adverse events (SAEs) [ Time Frame: up to 156 weeks ]
  2. Incidence of cardiovascular events [ Time Frame: up to 156 weeks ]
  3. The change between baseline and observation period in Haemoglobin A1c (HbA1c) [ Time Frame: up to 156 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
3000 patients with type 2 Diabetes Mellitus
Criteria

Inclusion criteria:

Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.

Exclusion criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904383


Locations
Germany
CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites
Ingelheim am Rhein, Germany, 55216
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01904383     History of Changes
Other Study ID Numbers: 1218.147
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases